Systems and methods for treating tissue with radiofrequency energy

ABSTRACT

A system for controlling operation of a radiofrequency treatment device to apply radiofrequency energy to tissue to heat tissue to create lesions without ablating the tissue. The system includes a first treatment device having at least one electrode for applying radiofrequency energy to tissue, a controller including a connector to which a first treatment device is coupled for use, and a generator for applying radiofrequency energy to the electrodes. The controller controls application of energy so that the tissue is thermally treated to create lesions but preventing thermal treatment beyond a threshold which would ablate the tissue.

RELATED APPLICATIONS

This application claims the benefit of provisional application Ser. No.61/664,960, filed Jun. 27, 2012 and is a continuation-in-part ofapplication Ser. No. 12/924,155, filed Sep. 22, 2010 which claims thebenefit of provisional application Ser. No. 61/277,260 filed 22 Sep.2009. The entire contents of each of these applications are incorporatedherein by reference.

FIELD OF THE INVENTION

In a general sense, the invention is directed to systems and methods fortreating interior tissue regions of the body. More specifically, theinvention is directed to systems and methods for treating dysfunction inbody sphincters and adjoining tissue by applying radiofrequency energyto tissue to create tissue lesions without ablating tissue.

BACKGROUND OF THE INVENTION

The gastrointestinal (GI) tract, also called the alimentary canal, is along tube through which food is taken into the body and digested. Thealimentary canal begins at the mouth, and includes the pharynx,esophagus, stomach, small and large intestines, and rectum. In humanbeings, this passage is about 30 feet (9 meters) long.

Small, ring-like muscles, called sphincters, surround portions of thealimentary canal. In a healthy person, these muscles contract or tightenin a coordinated fashion during eating and the ensuing digestiveprocess, to temporarily close off one region of the alimentary canalfrom another region of the alimentary canal.

For example, a muscular ring called the lower esophageal sphincter (orLES) surrounds the opening between the esophagus and the stomach.Normally, the lower esophageal sphincter maintains a high-pressure zonebetween fifteen and thirty mm Hg above intragastric pressures inside thestomach.

In the rectum, two muscular rings, called the internal and externalsphincter muscles, normally keep fecal material from leaving the analcanal. The external sphincter muscle is a voluntary muscle, and theinternal sphincter muscle is an involuntary muscle. Together, byvoluntary and involuntary action, these muscles normally contract tokeep fecal material in the anal canal.

Dysfunction of a sphincter in the body can lead to internal damage ordisease, discomfort, or otherwise adversely affect the quality of life.For example, if the lower esophageal sphincter fails to functionproperly, stomach acid may rise back into the esophagus. Heartburn orother disease symptoms, including damage to the esophagus, can occur.Gastrointestinal reflux disease (GERD) is a common disorder,characterized by spontaneous relaxation of the lower esophagealsphincter.

Damage to the external or internal sphincter muscles in the rectum cancause these sphincters to dysfunction or otherwise lose their tone, suchthat they can no longer sustain the essential fecal holding action.Fecal incontinence results, as fecal material can descend through theanal canal without warning, stimulating the sudden urge to defecate. Thephysical effects of fecal incontinence (i.e., the loss of normal controlof the bowels and gas, liquid, and solid stool leakage from the rectumat unexpected times) can also cause embarrassment, shame, and a loss ofconfidence, and can further lead to mental depression.

In certain surgical systems, radiofrequency energy is applied to tissueat different tissue levels to create multiple tissue lesions.Application of such energy requires continuous monitoring of certaintissue and/or device parameters to ensure that the tissue is not heatedto such extent that damaging burning of tissue occurs. Thus, thesesystems monitor tissue temperature and/or device electrode temperatureand provide safety features to cut off energy flow if the tissuetemperature rises too high. However, with the application ofradiofrequency energy, there is a fine point in which tissue is treatedto form lesions and beneficially alter structure of the tissue, e.g.,alter the structure of the sphincter muscle, while not being ablated orburned.

Ablation of tissue can be generally defined as a removal of a part oftissue. Radiofrequency energy to ablate tissue has been used for varioustumor treatments, destroying tissue and creating tissue necrosis.However, avoiding tissue ablation may be beneficial in treating thegastrointestinal tract in the foregoing or other procedures. Therefore,it would be advantageous to provide a system of applying radiofrequencyenergy to tissue at a power setting and time duration which causesthermal effect to tissue to create tissue lesions along a series oftissue levels but avoids ablation or burning of tissue.

However, in avoiding tissue ablation, care needs to be taken to ensurethat tissue is not undertreated. In other words, in attempts to preventoverheating of tissue which causes ablation, the system needs toconversely ensure that tissue is not under-heated and thus nottherapeutically treated. Therefore, the need exists for a system thatapplies radiofrequency energy to tissue between these two energy levels.

SUMMARY OF THE INVENTION

The present invention advantageously provides an electrosurgical systemthat applies radiofrequency energy to tissue to create tissue lesions atdifferent tissue levels and alters the structure of the tissue, e.g.,the sphincter muscle, without ablating or burning the tissue, while onthe other hand reducing the incidence of tissue undertreatment. This isachieved in one aspect by accurate calibration of the tissue temperaturemeasurement mechanism and improvement of appropriate reading andresponse to high tissue temperatures. This is achieved in another aspectby improved application of cooling fluid to the tissue during thesurgical procedure to provide quick response to rising tissuetemperatures. This is achieved in still another aspect by placement ofdata collection hardware in the treatment device, closer to the source.This is achieved in yet another aspect by providing a visual warning tothe user of too high a temperature as soon as the needle electrodes aredeployed before energy is applied. In yet another aspect, accuratespacing of tissue level treatments is achieved to reduce overlapping ofenergy application.

Moreover, the present invention advantageously provides suchelectrosurgical system that avoids such overheating of tissue, while atthe same time limiting under-heating of tissue which does noteffectively treat tissue. Thus, in striking this balance between theoverheating and under heating of tissue, more reliable and consistenttissue treatment is achieved.

This prevention of undertreatment is achieved in various ways, alldesigned to avoid disabling/cut off of energy to the electrodes if suchcutoff is not warranted. In one aspect, avoidance of undertreatment isachieved by more accurate temperature reading due to placement of thedata collecting hardware in the surgical treatment device and shieldingthe hardware, thereby reducing susceptibility to noise which can disruptcommunication and reporting this collected data to thecontroller/generator. In another aspect, a multiple checking of errorsconfirms that energy cutoff is really warranted.

The foregoing different aspects utilized to achieve the desired tissuetreatment can be implemented alone or in combination with each other.

Thus, the system and method of the present invention advantageouslykeeps tissue treatment within a target zone to provide a therapeuticeffect to tissue, defined as thermally heating tissue above a lowerparameter wherein tissue is undetreated and below a tissue ablationthreshold wherein tissue is overheated and ablated.

In one embodiment of the present invention a system for controllingoperation of a radiofrequency treatment device to apply radiofrequencyenergy to tissue to heat tissue to create tissue lesions withoutablating the tissue is provided. The system includes a first treatmentdevice having at least one electrode for applying radiofrequency energyto tissue, a controller including a connector to which a first treatmentdevice is coupled for use, and a generator for applying radiofrequencyenergy to the electrodes. The controller controls application of energyso that the tissue is thermally treated to create lesions but preventsthermal tissue. The controller can further include an operation systemto execute on a display screen a first graphical interface guiding useof the first treatment device, the controller visually prompting a userin a step-wise fashion to perform a process using the connectedtreatment device of forming a pattern of lesions in a body region in aplurality of axially spaced lesion levels, each lesion level including aplurality of circumferential spaced lesions.

In some embodiments, the treatment device includes a handle and ashielded printed circuit board contained in the handle, the printedcircuit board enabling precise measurement of tissue and electrodeparameters to regulate tissue temperature to prevent thermal treatmentof tissue beyond the threshold, and the shield reducing interference.

In some embodiments, the controller automatically increases the flow ofcooling fluid to the tissue if a tissue temperature exceeds apredetermined value to thereby reduce the tissue temperature to preventthermal treatment of tissue beyond the threshold.

In some embodiments, the printed circuit board is calibrated inmanufacture to improve the temperature accuracy to prevent thermaltreatment of tissue beyond the threshold.

In another embodiment, the present invention provides a method oftreating fecal incontinence comprising the steps of:

providing a treatment device having a plurality of electrodes;

applying radiofrequency energy to the electrodes to thermally treattissue below a tissue ablation threshold and create a plurality oftissue lesions along axially spaced tissue levels within the anal canal;

monitoring tissue temperature throughout the procedure; and

regulating power ensuring in response to the monitoring step that thetissue temperature does not exceed a predetermined value which wouldcause tissue ablation and/or tissue necrosis.

In some embodiments, the ensuring step is achieved by providing anautomatic cooling system to apply cooling fluid to the tissue if ameasured temperature exceeds a predetermined value.

In some embodiments, the ensuring step is achieved by placement of aprinted circuit board in a handle of the treatment device so tissuetemperature monitoring occurs closer to the target tissue to therebyimprove accuracy of temperature reading.

In some embodiments, the ensuring step is achieved by placement of aprinted circuit board adjacent to and external of a handle of thetreatment device so tissue temperature monitoring occurs closer totarget tissue to thereby improve the accuracy of temperature reading.

In some embodiments, the printed circuit board is calibrated inmanufacture to improve the accuracy of the temperature reading.

In another embodiment, the present invention provides a method oftreating gastrointestinal reflux disease comprising the steps of:

providing a treatment device having a plurality of electrodes;

applying radiofrequency energy to the electrodes to thermally treattissue below a tissue ablation threshold and create a plurality oftissue lesions along axially spaced tissue levels within the uppergastrointestinal tract;

monitoring tissue temperature throughout the procedure; and

regulating power ensuring in response to the monitoring step that thetissue temperature does not exceed a predetermined value which wouldcause tissue ablation and/or tissue necrosis.

In some embodiments, the ensuring step is achieved by providing anautomatic cooling system to apply cooling fluid to the tissue if ameasured temperature exceeds a predetermined value.

In some embodiments, the ensuring step is achieved by placement of aprinted circuit board in a handle of the treatment device so tissuetemperature monitoring occurs closer to target tissue to thereby improvethe accuracy of temperature reading.

In some embodiments, the ensuring step is achieved by placement of aprinted circuit board adjacent to and external of a handle of thetreatment device so temperature monitoring occurs closer to targettissue to thereby improve the accuracy of temperature reading.

In some embodiments, the printed circuit board is calibrated inmanufacture to increase accuracy of the temperature reading.

The present invention also provides in another aspect a method of atreating tissue by applying non-ablative radiofrequency energycomprising the steps of providing an instrument with a plurality ofelectrodes;

placing the electrodes near a sphincter to be treated; and

applying through the electrodes radiofrequency energy which is a)sufficient to increase the smooth muscle to connective tissue withoutchanges to the collagen I/III ratio to thereby remodel the sphincter butb) insufficient to ablate the tissue.

In some embodiments, the application of radiofrequency energy reinforcesthe sphincter.

In some embodiments, the step of providing the electrodes near thesphincter provides the electrodes near the internal anal sphincter.

The present invention also provides in another aspect a system forcontrolling operation of a radiofrequency treatment device to applyradiofrequency energy to tissue to heat tissue to create lesions at atreatment range defined between under heating tissue to fail to achievea therapeutic affect and overheating tissue to cause tissue ablation.The system comprises a controller including a connector to which a firsttreatment device having a plurality of electrodes for applyingradiofrequency energy to tissue is coupled for use, and a generator forapplying radiofrequency energy to the electrodes. The improvementcomprises a multiple error checking system which if an error is detectedwhich indicates disabling of an electrode of the treatment device, thesystem checks for a repeat of the error and determines if disabling iswarranted or energy application is warranted to thereby reduce thelikelihood of under treatment of tissue.

In some embodiments, the multiple error checking system repeats theerror check three times.

The present invention also provides in another aspect a system forcontrolling operation of a radiofrequency treatment device to applyradiofrequency energy to tissue to heat tissue to create tissue lesionsat a treatment range defined between overheating tissue to causeablation and under heating tissue to fail to achieve a therapeuticeffect. The system comprises a controller including a connector to whicha first treatment device having a plurality of electrodes for applyingradiofrequency energy to tissue is coupled for use, and a generator forapplying radiofrequency energy to the electrodes. The controllercontrols application of energy so that the tissue is thermally treatedto create tissue lesions but prevents thermal treatment beyond athreshold which would ablate the tissue. The system further includes acut off feature to cut off energy flow to disable an electrode if one ofmultiple potential errors is detected, the system further containing afeature to prevent premature disabling of an electrode.

In some embodiments, the feature to prevent premature disabling of anelectrode comprises a multiple error check in which if an error isdetected, a measurement is rechecked to determine if the error is stillpresent before cut off of energy flow.

In some embodiments, the system further comprises an automatic pumpsystem to increase the flow of cooling fluid if measured temperatureexceeds a predetermined value.

In some embodiments, the system further comprises an operation system toexecute on a display screen a first graphical interface guiding use ofthe first treatment device coupled to the controller, the controllervisually prompting a user in a step-wise fashion to perform a processusing the couple treatment device of forming a pattern of lesions in abody region in a plurality of axially spaced lesion levels, each lesionlevel including a plurality of circumferential spaced lesions

In some embodiments of such systems and methods, a graphical display isprovided for visually prompting a user in a step-wise fashion to use atreatment device to perform a process of forming a pattern of lesions ina body region comprising a plurality of axially spaced lesion levels,each lesion level comprising a plurality of circumferential spacedlesions. The systems and methods include registering the formation oflesions as they are generated in real time, both within and between eachcircumferentially spaced level, whereby the graphical display displaysfor the user a visual record of the progress of the process from startto finish and guides the user so that individual lesions desired withina given level are all formed, and that a given level of lesions is notskipped.

In some embodiments, the systems and methods include generating at eachlesion level a first stylized graphical image with a numberidentification of its level, and generating a second stylized graphicalimage, different from the first stylized graphical image, generated whenthe formation of lesions at a given level is indicated and furthershowing the number of lesions to be formed at that level. The systemsand methods include changing the second graphical image to a thirdgraphical image, different than the first or second images, includingadded indicia to reflect the formation of lesions in real time. Thesystems and methods may further include generating a marker that directsthe user to the next lesion level to be treated and that is updated assuccessive lesion levels are treated.

Further features and advantages of the inventions are set forth in thefollowing Description and Drawings, as well as in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic view of a unified system usable in associationwith a family of different treatment devices for treating bodysphincters and adjoining tissue regions in different regions of thebody.

FIG. 2 is a perspective view, with portions broken away, of one type oftreatment device usable in association with the system shown in FIG. 1to treat tissue in the upper gastro-intestinal tract, the treatmentdevice having an operative element for contacting tissue shown in acollapsed condition.

FIG. 2A is a perspective view of an alternate embodiment of thetreatment device of FIG. 2.

FIG. 2B is a perspective view of another alternate embodiment of thetreatment device of FIG. 2.

FIG. 3 is a perspective view, with portions broken away, of the deviceshown in FIG. 2, with the operative element shown in an expandedcondition.

FIG. 4 is a perspective view, with portions broken away, of the deviceshown in FIG. 2, with the operative element shown in an expandedcondition and the electrodes extended for use.

FIG. 5 is a lesion pattern that can be formed by manipulating the deviceshown FIGS. 2 to 4 in the esophagus at or near the lower esophagealsphincter and in the cardia of the stomach, comprising a plurality ofaxially spaced lesion levels, each lesion level comprising a pluralityof circumferential spaced lesions.

FIG. 6 is a perspective view of another type of treatment device usablein association with the system shown in FIG. 1 to treat tissue in thelower gastrointestinal tract, the treatment device having an array ofelectrodes shown in a retracted position.

FIG. 6A is a perspective view of an alternate embodiment of thetreatment device of FIG. 6.

FIG. 6B is a perspective view of another alternate embodiment of thetreatment device of FIG. 6.

FIG. 7 is a perspective view of the device shown in FIG. 6, with thearray of electrodes shown in their extended position.

FIG. 8 is a perspective view of the device shown in FIGS. 6 and 7, withthe array of electrodes shown in their extended position deployed in thelower gastrointestinal tract to treat sphincter dysfunction in the analcanal.

FIG. 9 is a lesion pattern that can be formed by manipulating the deviceas shown FIG. 8 in the anal canal at or near the anal sphincter,comprising a plurality of axially spaced lesion levels, each lesionlevel comprising a plurality of circumferential spaced lesions.

FIGS. 10A and 10B are, respectively, left and right perspective views ofone embodiment of an integrated device incorporating features of thesystem shown in FIG. 1 and usable with either treatment device shown inFIG. 2 or 6 for treating body sphincters and adjoining tissue regions,and also having a controller and a graphical user display for visuallyprompting a user in a step-wise fashion to use a treatment device toperform a process of forming a pattern of lesions in a body region likethat shown in FIG. 5 or 9, to guide the user so that individual lesionsdesired within a given level are all formed, and that a given level oflesions is not skipped.

FIG. 11 is a representative graphical user set-up display generated bythe controller prompting the user with numbers and/or text and/or iconsthrough the set-up and connection steps prior to a treatment procedure.

FIG. 12 is a representative graphical user set-up display generated bythe controller upon identifying the connection of a device like thatshown in FIGS. 2 to 4 (identified by the trademark STRETTA®).

FIG. 13 is a representative graphical user set-up display generated bythe controller upon identifying the connection of a device like thatshown in FIGS. 6 to 8 (identified by the trademark SECCA®).

FIGS. 14-A to 14-O are representative graphical user treatment displaysgenerated by the controller for visually prompting a user to use atreatment device like that shown in FIGS. 2 to 4 in a step-wise fashionto perform a process of forming a pattern of lesions in an esophaguslike that shown in FIG. 5, the graphical user display guiding the userand creating a visual record of the progress of the process from startto finish, so that individual lesions desired within a given level areall formed, and that a given level of lesions is not skipped.

FIG. 14P illustrates graphical user displays relating to ballooninflation of the device of FIG. 3.

FIG. 14Q illustrates the display of balloon inflation icon of FIG. 14P

FIGS. 15A to 15I are representative graphical user treatment displaysgenerated by the controller for visually prompting a user to use atreatment device like that shown in FIGS. 6 to 8 in a step-wise fashionto perform a process of forming a pattern of lesions in an anal canallike that shown in FIG. 9, the graphical user display guiding the userand creating a visual record of the progress of the process from startto finish, so that individual lesions desired within a given level areall formed, and that a given level of lesions is not skipped.

The invention may be embodied in several forms without departing fromits spirit or essential characteristics. The scope of the invention isdefined in the appended claims, rather than in the specific descriptionpreceding them. All embodiments that fall within the meaning and rangeof equivalency of the claims are therefore intended to be embraced bythe claims.

DESCRIPTION OF PREFERRED EMBODIMENTS

This Specification discloses various systems and methods for treatingdysfunction of sphincters and adjoining tissue regions in the body. Thesystems and methods are particularly well suited for treating thesedysfunctions in the upper and lower gastrointestinal tract, e.g.,gastro-esophageal reflux disease (GERD) affecting the lower esophagealsphincter and adjacent cardia of the stomach, or fecal incontinenceaffecting the internal and external sphincters of the anal canal. Forthis reason, the systems and methods will be described in this context.Still, it should be appreciated that the disclosed systems and methodsare applicable for use in treating other dysfunctions elsewhere in thebody, and dysfunctions that are not necessarily sphincter-related. Forexample, the various aspects of the invention have application inprocedures requiring treatment of hemorrhoids, or urinary incontinence,or restoring compliance to or otherwise tightening interior tissue ormuscle regions. The systems and methods that embody features of theinvention are also adaptable for use with systems and surgicaltechniques that are catheter-based and not necessarily catheter-based.

The systems and methods disclosed herein provide application ofradiofrequency energy to tissue via a plurality of electrodes. Theenergy is applied via the electrodes to tissue at a series of axiallyspaced tissue levels, thereby forming tissue lesions which alters thetissue structure. Prior application of radiofrequency energy to tissuein various surgical procedures involved application of energy at certainlevels and for a certain period of time with the goal to ablate thetissue. That is, the objective was to cause tissue necrosis and removetissue. The systems and methods of the present disclosure, however,treat tissue without ablating the tissue and without causing tissuenecrosis, which advantageously achieves better clinical results,especially when treating the sphincter muscles of the GI tract in thespecific surgical procedures disclosed herein. By applying sufficientenergy to cause thermal effect to tissue, but without ablating orburning the tissue, tissue reconstruction/remodeling occurs whichresults in beneficial changes to tissue properties, thus beneficiallytreating GERD which is caused by the spontaneous relaxation of the loweresophageal sphincter and beneficially treating fecal incontinence causedby loss of tone of the sphincter muscles in the anal canal. The systemof the present disclosure rejuvenates muscle to improve muscle function.The system of the present invention also increases the smoothmuscle/connective ratio which results in sphincter reinforcement andremodeling.

In studies performed, it was found that application of non-ablative RFenergy to sphincter muscle influences the structural arrangement ofsmooth muscle and connective tissue contents. The increase of the smoothmuscle fibers area per muscle bundles as well as the collagen andmyofibroblast contents within the internal anal sphincter were found tobe potentially responsible for sphincter reinforcement and remodeling.More specifically, in studies, it was found that application onnon-ablative RF energy increased smooth muscle/connective tissue ratiowithout changes (increase) in the collage I/III ratio. There was anincrease in diameter and number of type I fibers in the external analsphincter after non-ablative RF and higher cellular smooth musclecontent in the internal anal sphincter, suggesting that sphincterremodeling by non-ablative RF energy resulted from activation andrepopulation of smooth muscle cells, possibly related to phenotypeswitch of fibroblasts into myofibroblasts and external anal sphincterfibers. In one animal study, quantitative image analysis showed thecross-section occupied by smooth muscle within the circular muscleincreased by up to 16& after non-ablative RF, without increase incollagen I/III ratio, and external anal sphincter muscle fiber typecomposition showed an increase in type I/III fiber ratio from 26.2% to34.6% after non-ablative RF, as well as a 20% increase in fiber I typediameter compared to controls.

For such aforedescribed non-ablation RF treatment, the system and methodof the present disclosure also is designed to enhance lesion creation byavoiding unnecessary cutoff energy flow to electrodes in response to aperceived error.

Various features of the controller and/or surgical treatment devicesconnected to the controller achieve the foregoing. Preventingoverheating of tissue is achieved by enhanced temperature control of thetissue, which is accomplished in one way by more accurate temperaturemeasurement so proper power adjustments can be made to address risingtemperatures and accomplished in another way by enhanced application ofcooling fluid.

Preventing undertreatment of tissue is achieved in one way by locationof the data collecting hardware closer to the source and achieved inanother way by ensuring error detection does not lead to prematurecutoff of energy flow. Each of these are ways are described in detailbelow.

I. Overview of the System

FIG. 1 shows a unified system 24 for diagnosing and/or treatingdysfunction of sphincters and adjoining tissue in different regions ofthe body. In the illustrated embodiment, the system 24 is configured todiagnose and treat dysfunction in at least two distinct sphincterregions within the body.

The targeted sphincter regions can vary. In the illustrated embodiment,one region comprises the upper gastro-intestinal tract, e.g., the loweresophageal sphincter and adjacent cardia of the stomach. The secondregion comprises the lower gastrointestinal tract, e.g., in theintestines, rectum and anal canal.

The system 24 includes a family of treatment devices 26 a and 26 b. Eachdevice 26 a and 26 b can be specifically configured according to thephysiology and anatomy of the particular sphincter region which it isintended to treat. The details of construction of each device 26 a and26 b will be generally described later.

Each device 26 a/26 b carries an operative element 36 a and 36 b. Theoperative element 36 a and 36 b can be differently configured accordingto the physiology and anatomy of the particular sphincter region whichit is intended to treated. Still, if the anatomy and physiology of thetwo treatment regions are the same or similar enough, the configurationof the operative elements 36 a and 36 b can be same or essentially thesame.

In the illustrated embodiment, the operative elements 36 a and 36 bfunction in the system 10 to apply energy in a selective fashion totissue in or adjoining the targeted sphincter region. The applied energycreates one or more lesions, or a prescribed pattern of lesions, belowthe surface of the targeted region without ablating tissue. Thesubsurface lesions are desirably formed in a manner that preserves andprotects the surface against thermal damage.

Natural healing of the subsurface lesions leads to areconstruction/remodeling of the tissue which leads to beneficialchanges in properties of the targeted tissue. The subsurface lesions canalso result in the interruption of aberrant electrical pathways that maycause spontaneous sphincter relaxation. In any event, the treatment canrestore normal closure function to the sphincter region 18 as thenon-ablating application of radiofrequency energy beneficially changesthe properties of the sphincter muscle wall. Such energy rejuvenates themuscle to improve muscle function.

The system 24 includes a generator 38 to supply the treatment energy tothe operative element 36 a/36 b of the device 26 a/26 b selected foruse. In the illustrated embodiment, the generator 38 supplies radiofrequency energy, e.g., having a frequency in the range of about 400 kHzto about 10 mHz. Of course, other forms of energy can be applied, e.g.,coherent or incoherent light; heated or cooled fluid; resistive heating;microwave; ultrasound; a tissue ablation fluid; or cryogenic fluid.

A selected device 26 a/26 b can be individually coupled to the generator38 via a cable 10 to convey the generated energy to the respectiveoperative element 36 a/36 b.

The system 24 preferably also includes certain auxiliary processingequipment. In the illustrated embodiment, the processing equipmentcomprises an external fluid delivery apparatus 44 and an externalaspirating apparatus 46.

A selected device 26 a/26 b can be connected via tubing 12 to the fluiddelivery apparatus 44, to convey processing fluid for discharge by ornear the operative element 36 a/36 b. A selected device 26 a/26 b canalso be connected via tubing 14 to the aspirating apparatus 46, toconvey aspirated material from or near from the operative element 36a/36 b for discharge.

The system 24 also includes a controller 52. The controller 52, whichpreferably includes a central processing unit (CPU), is linked to thegenerator 38, the fluid delivery apparatus 44, and the aspiratingapparatus 46. Alternatively, the aspirating apparatus 46 can comprise aconventional vacuum source typically present in a physician's suite,which operates continuously, independent of the controller 52.

The controller 52 governs the power levels, cycles, and duration thatthe radio frequency energy is distributed to the particular operativeelement 36 a/36 b, to achieve and maintain power levels appropriate toachieve the desired treatment objectives. In tandem, the controller 52also desirably governs the delivery of processing fluid and, if desired,the removal of aspirated material. Thus, the controller maintains thetarget tissue temperature to ensure the tissue is not overheated.

The controller 52 includes an input/output (I/O) device 54. The I/Odevice 54 allows the physician to input control and processingvariables, to enable the controller to generate appropriate commandsignals. The I/O device 54 also receives real time processing feedbackinformation from one or more sensors associated with the operativeelement (as will be described later), for processing by the controller52, e.g., to govern the application of energy and the delivery ofprocessing fluid.

The I/O device 54 also includes a graphical user interface (GUI), tographically present processing information to the physician for viewingor analysis. Further details regarding the GUI will be provided later.

II. The Treatment Devices

The structure of the operative element 36 can vary. Variousrepresentative embodiments will be described.

A. For Treatment of Upper Gastro-Intestinal Tract

FIGS. 2 to 4 show a catheter-based device 26 a for treating sphincterregions in the upper gastro-intestinal tract, and more particularly, thelower esophageal sphincter and adjoining cardia of the stomach to treatGERD. In the embodiment shown, the device 26 a includes a flexiblecatheter tube 30 that carries a handle 28 at its proximal end. Thedistal end of the catheter tube 30 carries the operative element 36 a.

In the illustrated embodiment, the operative element 36 a comprises athree-dimensional basket 56. The basket 56 includes one or more spines58, and typically includes from four to eight spines 58, which areassembled together by a distal hub 60 and a proximal base 62. In theillustrated embodiment, four spines 58 are shown, spacedcircumferentially at 90-degree intervals.

In the illustrated embodiment, an expandable structure 72 comprising aballoon is located within the basket 56. The balloon structure 72 can bemade, e.g., from a Polyethylene Terephthalate (PET) material, or apolyamide (non-compliant) material, or a radiation cross-linkedpolyethylene (semi-compliant) material, or a latex material, or asilicone material, or a C-Flex (highly compliant) material.

The balloon structure 72 presents a normally, generally collapsedcondition, as FIG. 2 shows. In this condition, the basket 56 is alsonormally collapsed about the balloon structure 72, presenting a lowprofile for deployment into the esophagus.

A catheter tube 30 includes an interior lumen, which communicates withthe interior of the balloon structure 72. A fitting 76 (e.g., asyringe-activated check valve) is carried by the handle 28. The fitting76 communicates with the lumen. The fitting 76 couples the lumen to asyringe 78 (see FIG. 3). The syringe 78 injects fluid under pressurethrough the lumen into the balloon structure 72, causing its expansion.

Expansion of the balloon structure 72 urges the basket 56 to open andexpand (see FIG. 3). The force exerted by the balloon structure 72, whenexpanded, is sufficient to exert an opening or dilating force upon thetissue surrounding the basket 56 (see FIG. 31). The balloon can beexpanded to varying diameters to accommodate for varying patientanatomy.

Each spine 58 carries an electrode 66 (see FIG. 4). Therefore, there arefour electrodes circumferentially spaced at 90-degree intervals. In theillustrated embodiment, each electrode 66 is carried within the tubularspine 58 for sliding movement. Each electrode 66 slides from a retractedposition, withdrawn in the spine 58 (shown in FIG. 3) and an extendedposition, extending outward from the spine 58 (see FIG. 4) through ahole in the spine 58. A push-pull lever 68 on the handle 28 is coupledby one or more interior wires to the sliding electrodes 66. The lever 68controls movement of the electrodes between the retracted position (bypulling rearward on the lever 68) and the extended position (by pushingforward on the lever 68).

The electrodes 66 have sufficient distal sharpness and strength, whenextended, to penetrate a desired depth into tissue the smooth muscle ofthe lower esophageal sphincter 18 or the cardia of the stomach 16 (seeFIG. 32). The desired depth can range from about 4 mm to about 5 mm.

The electrodes 66 are formed of material that conducts radio frequencyenergy, e.g., nickel titanium, stainless steel, e.g., 304 stainlesssteel, or a combination of nickel titanium and stainless steel.

In the illustrated embodiment (see FIG. 4), an electrical insulatingmaterial 70 is coated about the proximal end of each electrode 66. Whenthe distal end of the electrode 66 penetrating the smooth muscle of theesophageal sphincter 18 or cardia 20 transmits radio frequency energy,the material 70 insulates the mucosal surface of the esophagus 10 orcardia 20 from direct exposure to the radio frequency energy. Thermaldamage to the mucosal surface is thereby avoided. The mucosal surfacecan also be actively cooled during application of radio frequencyenergy, to further protect the mucosal surface from thermal damage.

In the illustrated embodiment (see FIG. 4), at least one temperaturesensor 80 is associated with each electrode. One temperature sensor 80senses temperature conditions near the exposed distal end of theelectrode 66, a second temperature sensor 80 is located on thecorresponding spine 58, which rests against the mucosal surface when theballoon structure 72 is inflated.

The external fluid delivery apparatus 44 is coupled via tubing 12 (seeFIG. 1) to connector 48 (see FIG. 4), to supply cooling liquid to thetargeted tissue, e.g., through holes in the spines. The externalaspirating apparatus 46 is coupled via tubing 14 (see FIG. 1) toconnector 50 (see FIG. 4), to convey liquid from the targeted tissuesite, e.g., through other holes in the spine or elsewhere on the basket56. The controller 52 can govern the delivery of processing fluid and,if desired, the removal of aspirated material.

The controller 52 can condition the electrodes 66 to operate in amonopolar mode. In this mode, each electrode 66 serves as a transmitterof energy, and an indifferent patch electrode (described later) servesas a common return for all electrodes 66. Alternatively, the controller52 can condition the electrodes 66 to operate in a bipolar mode. In thismode, one of the electrodes comprises the transmitter and anotherelectrode comprises the return for the transmitted energy. The bipolarelectrode pairs can include electrodes 66 on adjacent spines, orelectrodes 66 spaced more widely apart on different spines.

In use, the device 26 a is manipulated to create a preferred pattern ofmultiple lesions comprising circumferential rings of lesions at severalaxially spaced-apart levels (about 5 mm apart), each level comprisingfrom 8 to 12 lesions. A representative embodiment of the lesion patternis shown in FIG. 5. As FIG. 5 shows, the rings are preferably formed inthe esophagus in regions above the stomach, at or near the loweresophageal spincter, and/or in the cardia of the stomach. The rings inthe cardia are concentrically spaced about the opening funnel of thecardia. At or near the lower esophageal sphincter, the rings are axiallyspaced along the esophagus.

Multiple lesion patterns can be created by successive extension andretraction of the electrodes 66, accompanied by rotation and/or axialmovement of the catheter tube to reposition the basket 56. The physiciancan create a given ring pattern by expanding the balloon structure 72and extending the electrodes 66 at the targeted treatment site, to forma first set of four lesions. The physician can then withdraw theelectrodes 66, collapse the balloon structure 72, and rotate thecatheter tube 30 by a desired amount, e.g., 30-degrees or 45-degrees,depending upon the number of total lesions desired within 360-degrees.The physician can then again expand the structure 72 and again extendthe electrodes 66, to achieve a second set of four lesions. Thephysician repeats this sequence until a desired number of lesions withinthe 360-degree extent of the ring is formed. Additional lesions can becreated at different levels by advancing the operative element axially,gauging the ring separation by external markings on the catheter tube.

As shown in FIG. 5, a desirable pattern comprises an axially spacedpattern of six circumferential lesions numbered Level 1 to Level 6 in aninferior direction, with some layers in the cardia of the stomach, andothers in the esophagus above the stomach at or near the loweresophageal sphincter. In the embodiment shown in instant FIG. 5, in theLevels 1, 2, 3, and 4, there are eight lesions circumferentially spaced45-degrees apart (i.e., a first application of energy, followed by a45-degree rotation of the basket 56, followed by a second application ofenergy). In the Levels 5 and 6, there are twelve lesionscircumferentially spaced 30-degrees apart (i.e., a first application ofenergy, followed by a 30-degree rotation of the basket 56, followed by asecond application of energy, followed by a 30-degree rotation of thebasket 56, followed by a third application of energy). In Level 5, theballoon structure 72 is only partially expanded, whereas in Level 6, theballoon structure 72 is more fully expanded, to provide lesion patternsthat increase in circumference according to the funnel-shaped spaceavailable in the funnel of the cardia.

Note that to secure against overinflation of the balloon, especially intissue Levels 1-4 where the device is positioned in the esophagus, apressure relief valve is attached to the air syringe, upstream of theballoon inflation port of the device, to allow air to escape if pressurelevels are exceeded. That is, in Levels 1-4, the air syringe is filledwith air, and the balloon is inflated to a target pressure so there isenough contact to slightly tension the tissue but not enough to stretchthe tissue, with the pressure relief ensuring the pressure is notexceeded. Preferably, the balloon would be inflated to no more thanabout 2.5 psi. In the stomach, at Levels 5 and 6, there is more room forthe balloon inflation, so the balloon can be further inflated and thepressure relief valve can be removed. The balloon is preferably inflatedby volume to about 25 ml for treatment at Level 5, and after treatmentat Level 5, deflated at Level 6 to about 22 ml. Note at Levels 5 and/or6, the inflated balloon can also be used as an anchor. In an alternateembodiment, after treatment of Level 4 the balloon is deflated and theinstrument is advanced, then retracted, wherein Level 6 is treated, thenthe instrument is pulled further proximally to subsequently treat Level5. Stated another way, Level 5 can be considered distal of Level 6 andtherefore being more distal, treated before Level 6. Note the balloonwould still be inflated to about 25 ml in the more distal level and toabout 22 ml in this embodiment. The balloon can also serve as an anchor.

In an alternate embodiment of the treatment device 26 a, one or moredigital cameras can be mounted along the catheter tube, e.g., with thecamera lens directed to the basket 56, to provide visualization of thesite. In another alternate embodiment, the catheter tube can be designedto fit within a lumen of an endoscope, relying on the endoscope forvisualization of the site.

B. For Treatment of Lower Gastro-Intestinal Tract

FIGS. 6 and 7 show a representative embodiment for device 26 b, whichtakes the form of a hand manipulated device 302 for treating sphincterregions in the lower gastro-intestinal tract, and more particularly, theinternal and/or external sphincter muscles in the anal canal to treatfecal incontinence. The device 302 includes a hand grip 304 that carriesthe operative element 36 b.

In the illustrated embodiment, the operative element 36 b takes the formof a hollow, tubular barrel 306 made from a transparent, molded plasticmaterial. The barrel 306 terminates with a blunt, rounded distal end 308to aid passage of the barrel 306 through the anal canal, without needfor a separate introducer. The hand grip 304 includes a viewing port 312for looking into the transparent, hollow interior of the barrel 306, tovisualize surrounding tissue.

An array of needle electrodes 316 are movably contained in aside-by-side relationship along an arcuate segment of the barrel 306. Inthe illustrated embodiment, the needle electrodes 316 occupy an arc ofabout 67.5 degrees on the barrel 306. The needle electrodes 316 aremechanically linked to a finger-operated pull lever 318 on the hand grip304. By operation of the pull lever 318, the distal ends of the needleelectrodes 316 are moved between a retracted position (FIG. 5) and anextended position (FIG. 6 of the '523 patent). An electrical insulatingmaterial 344 is coated about the needle electrodes 316 (see FIG. 6 ofthe '523 patent), except for a prescribed region of the distal ends,where radio frequency energy is applied to tissue. The generator 38 iscoupled via the cable 10 to a connector 352, to convey radio frequencyenergy to the electrodes 316.

In use (see FIG. 8), the physician grasps the hand grip 304 and guidesthe barrel 306 into the anal canal 320. The pull lever 318 is in theneutral position and not depressed, so the needle electrodes 316 occupytheir normal retracted position. Looking through the viewing port 312,the physician visualizes the pectinate (dentate) line through the barrel306. Looking through the barrel 306, the physician positions the distalends of the needle electrodes 316 at a desired location relative to thepectinate (dentate) line. A fiberoptic can also be located in the barrel306 to provide local illumination. Once the distal end of the barrel 306is located at the targeted site, the physician depresses the pull lever318 (as FIG. 8 shows). The needle electrodes 316 advance to theirextended positions. The distal ends of the electrodes 316 pierce andpass through the mucosal tissue into the muscle tissue of the targetsphincter muscle. In FIG. 8, the distal end of the electrodes 316 areshown penetrating the involuntary, internal sphincter muscle 322. Thephysician commands the controller 52 to apply radio frequency energythrough the needle electrodes 316. The energy can be appliedsimultaneously by all electrodes 316, or in any desired sequence.

The external fluid delivery apparatus 44 is coupled via tubing 12 to aconnector 348 to convey a cooling liquid, e.g., through holes in thebarrel 306, to contact tissue at a localized position surrounding theelectrodes 316. The external aspirating apparatus 46 is coupled viatubing 14 to a connector 350 to convey liquid from the targeted tissuesite, e.g., through an aspiration port 358 in the distal end 308 of thebarrel 306 (see FIGS. 6 and 7).

The barrel 306 (see FIG. 7) also preferably carries temperature sensor364, one of which is associated with each needle electrode 316. Thesensors 364 sense tissue temperature conditions in the region adjacentto each needle electrode 316. Preferably, the distal end of each needleelectrode 316 also carries a temperature sensor 372 (see FIG. 7).

In use (see FIG. 9), a preferred pattern of multiple lesions is formedcomprising several circumferential rings of lesions in axiallyspaced-apart levels (about 5 mm apart), each ring comprising 16 lesionsin four quadrants of 4 each. The rings are formed axially along the analcanal, at or near the dentate line.

The fluid delivery apparatus 68 conveys cooling fluid for discharge atthe treatment site, to cool the mucosal surface while energy is beingapplied by the needle electrodes 316. The aspirating apparatus 76 drawsaspirated material and the processing fluid through the tubing 78 fordischarge.

Referring to FIG. 9, the array of needle electrodes 316 is positioned atLevel 1 to create four multiple lesions in the first quadrant. Upon thesatisfactory creation of the lesion pattern in the first quadrant ofLevel 1, as just described, the physician actuates the button 64 torelease the locking pawl 58 from the detent 62. The pull lever 318returns to the spring-biased neutral position, thereby moving the needleelectrodes 316 back to their retracted positions. Still grasping thehand grip 304 and visualizing through the viewing port 312, thephysician moves the barrel 5 mm axially upward to Level 2, the firstquadrant. The physician again deploys the needle electrodes 316 andperforms another lesion generating sequence. The physician repeats thissequence of steps until additional number of lesion patterns are formedwithin the axially spaced first quadrants in Levels 1, 2, 3, 4, and 5.

Still grasping the hand grip 304 and visualizing through the viewingport 312, the physician returns to level 1, and rotates the barrel 306 aselected arcuate distance at the level of the first lesion pattern 94 tothe second quadrant, i.e., by rotating the barrel 306 by ninety degrees.

The physician again deploys the needle electrodes 316 and performsanother lesion generating sequence at quadrant 2 of Level 1. Thephysician then moves the barrel axially upward in 5 mm increments, at anumber of axially spaced levels 2, 3, 4, and 5 generally aligned withlesion patterns 96, 98, and 100. Lesions are formed in this way in thesecond quadrant of Levels 1, 2, 3, 4, and 5.

The physician repeats the above described sequence two additional times,returning the barrel to level 1 and rotating the barrel 306 atsuccessive intervals and axially repositioning the barrel 306 to formthe lesion patterns quadrants 3 and 4 in the Levels 1, 2, 3, 4, and 5.This protocol forms a composite lesion pattern 102, which provides adensity of lesions in the targeted sphincter tissue region to provoke adesired contraction of the sphincter tissue.

III. System Operation

In the illustrated embodiment (see FIGS. 10A and 10B), the radiofrequency generator 38, the controller 52 with I/O device 54, and thefluid delivery apparatus 44 (e.g., for the delivery of cooling liquid)are integrated within a single housing 400.

The I/O device 54 couples the controller 52 to a display microprocessor474 (see FIG. 10A). The display microprocessor 474 is coupled to agraphics display monitor 420 in the housing 400. The controller 52implements through the display microprocessor 474 the graphical userinterface, or GUI, which is displayed on the display monitor 420. Thegraphical user interface can be realized with conventional graphicssoftware using the MS WINDOWS® application. The GUI is implemented byshowing on the monitor 420 basic screen displays.

A. Set-Up

Upon boot-up of the CPU (see FIG. 11), the operating system implementsthe SET-UP function for the GUI 500. The GUI displays an appropriatestart-up logo and title image (not shown), while the controller 52performs a self-test. An array of SETUP prompts 502 leads the operatorin a step-wise fashion through the tasks required to enable use of thegenerator and device. The physician can couple the source of coolingliquid to the appropriate port on the handle of the device 26 a/26 b(see FIG. 10A, as previously described) and load the tubing leading fromthe source of cooling liquid (e.g., a bag containing sterile water) intothe pump rotor 428 (see FIG. 10B). The physician can also couple theaspiration source 46 to the appropriate port on the handle of thetreatment device 26 a/26 b (as also already described). The physiciancan also couple the patch electrode 412 and foot pedal 416 (shown inFIG. 10A). In the SET-UP prompt array 502, a graphic field of the GUI500 displays one or more icons and/or alpha-numeric indicia 502 thatprompt the operator to connect the return patch electrode 412, connectthe foot pedal or switch 416, connect the selected treatment device 26 a(designed by its trademark STRETTA®) or 26 b (designated by itstrademark SECCA®), and to prime the irrigation pump 44.

Note in some embodiments, the user controls the pump speed to increasefluid flow if the temperature is rising. In alternate embodiments, thesystem is designed with an automatic cooling feature, thus enablingquicker application of cooling fluid to address rising tissuetemperatures to faster cool the tissue surface which in turn cools theunderlying tissue which helps to maintain the tissue temperature belowthe “tissue ablation threshold.”

More specifically, at certain tissue temperatures, the speed of the pumpis changed automatically to reduce the temperature. That is, if thetissue surface temperature, e.g., at the mucosa layer as measured by thetissue temperature sensor, reaches a certain threshold (a “firstvalue”), the pump speed will increase to pump more cooling fluid to thetissue. In some embodiments, for certain tissue temperature values, thesystem can enable the user to override the automatic pump to reduce thefluid flow. In other embodiments, a user override feature is notprovided. In either case, the system is preferably designed so that if asecond predetermined higher temperature value (“second value”) isreached, the pump is automatically moved to its maximum pump speed,which preferably cannot be overridden by the user. When a thirdpredetermined still higher tissue temperature value is reached (a “thirdcutoff value”), the electrode channel is disabled as discussed herein toshut off energy flow to that electrode. Consequently, before the thirdcut off value is reached, as the temperature is rising, the systemprovides for a quicker response to the rising temperature byautomatically increasing fluid flow, rather than relying on the slowerresponse time of the user to implement the pump speed change, therebyhelping to keep temperature below the tissue ablation thresholdtemperature.

Exemplary tissue values are provided solely by way of example, it beingunderstood that other tissue values can also be utilized to achievequick application of cooling fluid and ensure the non-ablation, andnon-burning, of tissue. For example, in the upper GI tract treatmentdevice described herein (see FIG. 3), the first value could be about 38degrees, the second predetermined value could be about 40 degrees andthe third value where the energy is shut down could be about 43 degrees.For a lower GI tract treatment device described herein (see FIG. 6), thefirst value could be about 45 degrees, the second predetermined valuecould be about 46 degrees and the third value where the energy is shutdown could be about 54 degrees.

The controller 52 ascertains which device 26 a or 26 b has been selectedfor use by reading a coded identification component residing in thehandle of the device 26 a or 26 b. Based upon this input, the controller52 proceeds to execute the preprogrammed control and graphical GUIcommand functions for the particular device 26 a and 26 b that iscoupled to the generator.

If the identification code for the device 26 a, (STRETTA®) isregistered, the GUI displays an appropriate start-up logo and titleimage for the device 26 a (see FIG. 12). Likewise, if the identificationcode for the device 26 b (SECCA®) is registered, the GUI displays anappropriate start-up logo and title image for the device 26 b (FIG. 13).

In some embodiments, the coded identification device is part of aprinted circuit board (PCB) positioned in the handle of the treatmentdevice. The PCB for each device is illustrated generally in FIGS. 2A and6A, and designated by reference numerals 29, 329, respectively, andprocesses the calculated parameters. The PCB in conjunction withthermocouples provides a temperature measurement mechanism. The PCBmeasures the voltage generated by the thermocouples, converts it from ananalog to a digital value and stores it in the internal memory. Uponrequest by the generator, the PCB communicates the digital data to thegenerator. This step is performed during the 100 millisecond breakbetween radiofrequency pulses discussed below. By placement of thetemperature measurement mechanism in the treatment device, i.e., in thedisposable handpiece, rather than in the housing 400, data collection iscloser to the source which translates into less noise susceptibility andimproved accuracy. That is, since processing of temperature valuesoccurs closer to the tissue and electrode tip, measurements can be moreaccurate. More accurate readings translate into tighter power controlsand better clinical results and it better ensures the tissue is notablated during treatment as it is maintained below a tissue ablationthreshold.

In a preferred embodiment, the PCB, which is asymmetrically positionedwithin the handle, is shielded to reduce interference which couldotherwise disrupt communication between the disposable treatment deviceand the generator. Such interference (noise) could corrupt the data andunnecessarily result in system errors which can unnecessarily shut downenergy flow to the electrode(s) during the procedure. In a preferredembodiment, the shield is a copper foil, although other ways to shieldthe PCB are also contemplated. In other words, the disruption ofcommunication could adversely affect processing and evaluation of thedata collected by the treatment device. By eliminating such disruptions,and thereby disabling fewer electrodes improved consistency of treatmentis achieved. Also, as can be appreciated, if too many electrodes aredisabled in a procedure, the tissue may not be sufficiently thermallytreated to achieve the desired clinical result.

In an alternate embodiment of the treatment devices shown in FIGS. 2Band 6B, the identification code is positioned in the handle of thetreatment device 26 a, 26 b, generally designated by reference numerals29 a, 329 a, respectively, but the other hardware, e.g., the printedcircuit board for temperature calculation, etc. is outside the handleand represented generally by reference numeral 49 in FIG. 2B andreference numeral 340 in FIG. 6B. Thus, the temperature data collectionis performed outside the disposable treatment device which reduces costssince it need not be disposed of with the disposable treatment device.Note the embodiments of FIGS. 2B and 6B still have the advantage of datacollection closer to the source than if in the housing 400.

B. Treatment Screens (UGUI and LGUI)

Upon completion of the SET-UP operation, the controller 52 proceeds tocondition the generator and ancillary equipment to proceed step-wisethrough a sequence of operational modes. The operational modes have beenpreprogrammed to achieve the treatment protocol and objective of theselected device 26 a/26 b. The conduct of these operational modes andthe appearance of the graphical user interface that guides and informsthe user during the course of the selected procedure can differ betweendevices 26 a and 26 b.

For ease of description, the GUI 500 displays for the uppergastro-intestinal procedure (i.e., for the device 26 a) a treatmentscreen that will in shorthand be generally called UGUI 504 (FIG. 14A).Likewise, the GUI displays for the lower gastro-intestinal procedure(i.e., for the device 26 b) a treatment screen that will in shorthand begenerally called LGUI 506 (FIG. 15A).

In both the UGUI 504 (FIG. 14A) and LGUI 506 (FIG. 15A), there is aparameter icon 462 designating cooling fluid flow rate/priming. In boththe UGUI 504 and the LGUI 506, the Flow Rate/Priming Icon 462 shows theselected pump speed by the number of bars, one bar highlighting a lowspeed, two bars highlighting a medium speed, and three bars highlightinga high speed.

Each UGUI 504 (FIG. 14A) and LGUI 506 (15A) includes an Electrode Icon466. In general, each Electrode Icon 466 comprises an idealizedgraphical image, which spatially models the particular multipleelectrode geometry of the treatment device 26 a/26 b that has beencoupled to the controller 42. Just as the multiple electrode geometriesof the devices 26 a and 26 b differ, so, too, does the Electrode Icon466 of the UGUI 504 differ from the Electrode Icon 466 of the LGUI 506.

As FIG. 14A shows, in the UGUI 504, four electrodes are shown in thegraphic image of the Icon 466, which are spaced apart by 90 degrees.This graphic image reflects the geometry of the four-electrodeconfiguration of the device 26 a, as shown in FIG. 4.

As FIG. 15A shows, in the LGUI 506, four electrodes are shown in thegraphic image of Icon 466 in a circumferentially spaced relationshipalong a partial arcuate sector. This graphic image reflects thearrangement of electrodes on the treatment device 26 b, as shown in FIG.7.

For each electrode, the respective Icon 466 incorporates graphic regionsO1, O2, and O3 in the spatial display. Regions O1 and O2 displaytemperature conditions encountered for that electrode. Region O1numerically displays the magnitude of sensed electrode tip temperaturein UGUI 504 (FIG. 14A) and LGUI 506 (FIG. 15A). Region O2 numericallydisplays sensed tissue temperatures for that electrode in UGUI 504 (FIG.14A) and LGUI 506 (FIG. 15A). Region O3 displays the derived impedancevalue for each electrode. Both UGUI 504 and LGUI 506 displayinstantaneous, sensed temperature readings from the tip electrode andtissue surface, as well as impedance values, which are continuouslydisplayed in spatial relation to the electrodes in the regions O1, O2,and O3.

The numeric displays of the regions O1/O2/O3 can be blanked out for agiven electrode if the corresponding electrode/channel has beendisabled, either by the physician or by a sensed out-of-boundscondition. An “acceptable” color indicator (e.g., green) can also bedisplayed in the background of the regions O1/O2/O3 as long as thesensed condition is within the desired pre-established ranges. However,if the sensed conditions fall outside the desired range, the colorindicator changes to an “undesirable” color indicator (e.g., to grey),and numeric display is blanked out.

In a preferred embodiment, if an electrode/channel is disabled and theenergy is turned off for that electrode, the corresponding icon isgrayed out, but the numeric value remains on the screen, thus providinguseful information to the user. Thus, at the end of the surgicalprocedure, the reasons for the shut down of the particular electrode canbe evaluated so the user can learn what if any user errors occurred.

In some embodiments, temperature of the needle tips is measured when theneedles are deployed at the lesion level, but prior to application of RFenergy. If the measured temperature exceeds an expected value, thetemperature reading alerts the user that the needle position might needto be readjusted. If the temperature value is too high, this can meanthat the electrode position is too close to the previous tissue leveltreated, and thereby the user can readjust the electrode position byincreasing the spacing, thereby reducing the chances of overtreating thetissue which can cause undesired tissue ablation or burning of tissue.Consequently, continuous treatment of tissue can be achieved withreduced overlapping of treatment.

Also, as can be appreciated, the temperature of the electrode tip, thetissue temperature and the impedance, along with other safetyparameters, such as adequate connections, are monitored during theprocedure to ensure energy flow is correct. This includes proper flowthrough the cable, electrodes, ground pad, etc. The electrode needle isthen disabled if a safety condition is suspected and indicated. Eachneedle can be controlled separately.

In use of the system, impedance is intermittently checked throughout theprocedure. Impedance is measured by measuring the current at the channelof the electrode tip. The impedance monitoring provides an indication ofhow well the treatment device is connected and communicating with thetissue, which includes the needle penetration and the path with thereturn pad. If there is not good contact between the electrode andtissue, impedance is high and a patient can get burned.

Therefore, if a patient moves, needle penetration could be affected.However, oftentimes a minor adjustment can be made which does notrequire shutting down energy flow. To avoid premature shutting down ofthe system a multiple error check is conducted by the system which isdescribed in more detail below. This multiple error check reduces theincidence of needle disabling which in turn reduces the incidence ofundertreatment.

Note the impedance is measured by applying a voltage, measuring thecurrent and calculating the impedance. The RF energy is applied in 0.9second intervals, with a 0.1 second break in between where an artificialpulse is sent for 0.1 second, in which impedance is measured. Thetemperature of the electrode tip and tissue temperature is also measuredduring this 0.1 second interval, for calculating such measurement.Preferably, the RF energy is repeatedly applied for 0.9 seconds, with0.1 second “measurement intervals” for a time period of 60 seconds.

There is also a Lesion Level Icon 510 in each display UGUI 504 and LGUI506, adjacent to the respective Electrode Icon 466. The Lesion LevelIcon 510 comprises an idealized graphical image, which spatially modelsthe desired lesion levels and the number of lesions in each level. Justas the lesion patterns created by the devices 26 a and 26 b differ, so,too, does the Lesion Level Icon 510 of the UGUI 504 differ from theElectrode Icon 466 of the LGUI 506.

As will be described in greater detail later, the Lesion Level Icons 510change in real time, to step-wise guide the physician through theprocedure and to record the progress of the procedure from start tofinish. In many fundamental respects, the look and feel of the LesionLevel Icons 510 for the LGUI 504 and the LGUI 506 are similar, but theydo differ in implantation details, due to the difference of theprotocols of lesion formation.

Exemplary changes in the Lesion Level Icons 510 for the UGUI 504 and theLGUI 506 will now be described.

1. The UGUI

In the UGUI 504 (se FIG. 14A), six numbered Lesion Levels 1, 2, 3, 4, 5,and 6 are displayed, to correspond with the lesion levels alreadydescribed and shown in FIG. 5. The UGUI 504 also displays a squiggleline 514, which marks where the physician has visualized a selectedanatomic home base reference for the formation of lesions within theesophagus for treatment. Guided by the UGUI 504, lesions are placedrelative to this anatomic home base.

In preparation for the treatment, the physician visualizes in theesophagus the Z-line or other desired anatomic landmark. Markers arearranged at 5 mm intervals along the catheter tube. Upon visualizing theZ-line, the physician notes the external marker on the catheter tubethat corresponds to this position. With reference to the markers, thephysician can then axially advance or retract the catheter tube in 5 mmincrements, which correspond to the desired spacing between the lesionlevels. This orientation of lesion levels is also shown in FIG. 5.

The UGUI 504 graphically orients the location of Lesion Levels 4, 5, and6 relative to this anatomical base, displaying Lesion Levels eitherbelow (inferior to) the squiggle line 514 (Lesion Levels 4, 5, and 6) orat or above the squiggle line 514 (Lesion Levels 1, 2, and 3).

As will be described, the UGUI 504 graphically changes the display ofthe Lesion Levels, depending upon the status of lesion formation withinthe respective levels.

FIG. 14A shows a representative first graphical form of a given lesionlevel. The graphical form comprises, e.g., a cylinder that facesedgewise on the UGUI 504, as is shown for Lesion Levels 1 to 6 in FIG.14A. This graphical form indicates at a glance that no lesions arepresent in the respective lesion levels.

As is shown in FIG. 14A, next to the graphical form of the edgewisecylinder of Lesion Level 1 is a Guide Marker 512. The Guide Marker 512indicates that formation of lesions in Lesion Level 1 is the first to beindicated. A numeric value (15 mm) is displayed in association with theedgewise cylinder of Lesion Level 1, which indicates that Lesion Level 1is 15 mm from the anatomic landmark. The orientation of Lesion Level 1above (superior to) the squiggle line 514 guides the physical to advancethe catheter tube upward from the anatomic marker by 15 mm, to place itat Lesion Level 1. A Balloon Icon 516 prompts the physician to expandthe basket of the device 26 a at Lesion Level 1.

Upon sensing electrode impedance, indicating contact with tissue atLesion Level 1 (or in response to another input indicating deployment ofthe device 26 a at the desired lesion level), the controller commandsthe UGUI 504 to change the graphical form of Lesion Level 1 to a secondgraphical form, which is shown in FIG. 14B. The second graphical form(shown in FIG. 14B) is different than the first graphical form (shown inFIG. 14A). The graphical form comprises, e.g., a segmented circle, witha numeric indicator next to it. This is shown for Lesion Level 1 in FIG.14B. In visual effect, the second graphical form shows the previouslycylinder form rotated for viewing along its axis. The number of segmentsshown (in FIG. 14B, there are eight segments) corresponds with thenumber of lesions that are to be formed at Lesion Level 1.

In FIG. 14B, all segments of the circle are unmarked. This graphicalform indicates at a glance that (i) formation of lesions at this lesionlevel is now indicated (due to the axial circle view of the lesion levelicon), (ii) eight circumferentially spaced lesions are to be formed (dueto the number of segments); (iii) no lesions have as yet been formed (bythe lack of other markings in the segments).

The location of the Marker 512 also changes to align with Lesion Level2, with a numeric indicator of 5 mm. This informs the physician that,after Lesion Level 1, the next lesion level to be treated is LesionLevel 2, which is 5 mm below (inferior to) Lesion Level 1.

With the device 26 a positioned at Lesion Level 1, the physicianactuates the electrodes for a first pre-set period. The balloon icon 516disappears as treatment progresses on a given level. A Timer Icon 518shows the application of radio frequency energy for the pre-set period.At the end of this pre-set period (see FIG. 14C), treatment indicia(e.g., dots) appear in four segments of the graphical segmented circle,indicating the formation of the first four lesions, as well as theirspatial orientation.

The open segments remaining in the segmented circle prompt the physicianto rotate the basket by 45-degrees, and actuate the electrodes forsecond time. After the pre-set period (tracked by the Timer Icon 518)(see FIG. 14D), more treatment indicia (the dots) appear in theremaining segments of the circle. This indicates that all the lesionsprescribed for Lesion Level 1 have been formed, and to deflate thebasket and move to the next treatment level. The Marker 512 that isdisplayed directs the physician to Lesion Level 2, which is 5 mm belowLesion Level 1. The Balloon Icon 516 can reappear to prompt thephysician to deflate the balloon.

The physician is thereby prompted to deflate the basket, move to LesionLevel 2, and expand the basket. As FIG. 14E shows, upon sensingelectrode impedance, indicating contact with tissue at Lesion Level 2,the UGUI 504 changes the graphical form of Lesion Level 1 back to anedgewise cylinder. The edgewise cylinder for Lesion Level 1 includes anindicator, e.g., checkmark, to indicate that Lesion Level 1 has beentreated (as shown in FIG. 14E). The insertion of the treatment completedindicator is yet another graphical form the UGUI 504 displays tocommunicate status information to the physician.

Also referring to FIG. 14E, upon sensing electrode impedance, indicatingcontact with tissue at Lesion Level 2, the UGUI 504 changes thegraphical form of Lesion Level 2 to the second graphical form,comprising, e.g., the segmented circle, as already described. This isshown for Lesion Level 2 in FIG. 14E. The location of the Marker 512also changes to align with Lesion Level 3, with a numeric indicator of 5mm. This informs the physician that after Lesion 2, the next lesionlevel will be Lesion Level 3, which is 5 mm below (inferior to) LesionLevel 2.

As shown in FIGS. 14F and 14G, with the device 26 a positioned at LesionLevel 2, the physician actuates the electrodes for a first pre-setperiod, then rotates the device 26 a 45-degrees, and actuates theelectrodes for the second pre-set period. The Timer Icon 518 reflectsthe application of radio frequency energy for the pre-set periods, andthe treatment indicia (e.g., dots) are added to the segments of thegraphical segmented circle, indicating the formation of the first fourlesions (FIG. 14F) and the next four lesions (FIG. 14G), as well astheir spatial orientation.

Upon formation of the eight lesions in Lesion Level 2, the balloon icon518 again appears. This indicates that all the lesions prescribed forLesion Level 2 have been formed, and to deflate the basket and move tothe next treatment level. The Marker 512 that is displayed directs thephysician to Lesion Level 3, which is 5 mm below Lesion Level 2.

The physician is thereby prompted to deflate the basket, move to LesionLevel 3, and expand the basket. Upon sensing electrode impedance,indicating contact with tissue at Lesion Level 3 (see FIG. 14H), theUGUI 504 changes the graphical form of Lesion Level 2 back to anedgewise cylinder (as FIG. 14H shows). The edgewise cylinder for LesionLevel 2 now includes an indicator, e.g., the checkmark, to indicate thatLesion Level 2 has been treated (as FIG. 14H also shows).

As FIG. 14I also shows, upon sensing electrode impedance, indicatingcontact with tissue at Lesion Level 3, the UGUI 504 changes thegraphical form of Lesion Level 3 to the second graphical form,comprising, e.g., the segmented circle, as already described. This isshown for Lesion Level 3 in FIG. 14H. The location of the Marker 512also changes to align with Lesion Level 4, with a numeric indicator of 5mm. This informs the physician that after Lesion 3, the next lesionlevel will be Lesion Level 3, which is 5 mm below (inferior to) LesionLevel 3.

The physician proceeds to form eight lesions in Lesion Level 3 (FIGS.141 and 14J), then moving on to Lesion Level 4 (not shown, but followingthe same progression as already described). All the while, the UGUI 504visually records and confirms progress. As shown in FIG. 14K, thegraphical Lesion Level cylinders for Lesion Levels 3 and 4 returnedgewise when the desired number of lesions has been formed on therespective level and treatment at the level has been completed. At thattime, a check mark appears on the edgewise cylinder, indicating thattreatment at that level has been completed for Lesion Levels 1, 2, 3,and 4 (as shown in FIG. 14K).

In FIGS. 14K to 14N, on Lesion Levels 5 and 6, the segments in thesegmented circle number twelve, indicating that twelve lesions are to beformed on these levels. In the Levels 5 and 6, there are twelve lesionscircumferentially spaced 30-degrees apart (i.e., a first application ofenergy, followed by a 30-degree rotation of the basket 56, followed by asecond application of energy, followed by a 30-degree rotation of thebasket 56, followed by a third application of energy). In Level 5, theballoon structure is only partially expanded, whereas in Level 6, theballoon structure 72 is more fully expanded, to provide lesion patternsthat increase in circumference according to the funnel-shaped spaceavailable in the funnel of the cardia.

The UGUI 504 reflects completion of the treatment (see FIG. 140).

In preferred embodiments, a series of icons related to balloon inflationare displayed on the graphical user interface. More specifically, assoon as the system is ready to begin treatment, a pressure relief valveicon as depicted in FIG. 14P appears on the treatment screen (see alsoFIG. 14Q). This icon 550 serves as a reminder to the user to utilize therelief valve, as described above, to prevent overinflation of theballoon at Lesion Levels 1-4. As soon as the treatment cycle begins, therelief valve icon 550 disappears from the screen. After treatment atLesion Levels 1-4, before treatment at Level 5 begins, balloon icon 552,which has a 25 ml label, appears to indicate inflation of the balloon to25 ml. Icon 552 disappears when treatment at Level 5 begins. Beforetreatment at Level 6, balloon icon 554 with a 22 ml label to remind theuser to deflate the balloon to 22 ml appears. Balloon icon 554disappears from the screen when treatment at Level 6 begins.

Thus, the UGUI 504, by purposeful manipulation of different stylizedgraphical images, visually prompts the physician step wise to perform aprocess of forming a pattern of lesions comprising a plurality ofaxially spaced lesion levels, each lesion level comprising a pluralityof circumferential spaced lesions. The UGUI 504 registers the formationof lesions as they are generated in real time, both within and betweeneach circumferentially spaced level. The UGUI 504 therefore displays forthe physician a visual record of the progress of the process from startto finish. The UGUI 504 assures that individual lesions desired within agiven level are not skipped, or that a given level of lesions is notskipped.

In the UGUI 508, each Lesion Level 1 to 6 is initially depicted by afirst stylized graphical image comprising an edgewise cylinder with anumber identification of its level. When the formation of lesions at agiven level is indicated, the UGUI 504 changes the first stylizedgraphical image into a second stylized graphical image, different thanthe first image, comprising an axial view of the cylinder, presented asa segmented circle, with the numbers of segments corresponding to thenumber of lesions to be formed. There also appears juxtaposed with thenext lesion level to be treated (still displayed as an edgewisecylinder), a marker along with a number indicating its distance from thepresent legion level. As the physician manipulates the device 26 a toform lesions on the indicated levels, the second graphical image furtherchanges to a third graphical image, different than the first or secondimages, by adding indicia within the segmented circle to reflect theformation of lesions, to guide the physician to successively rotate andoperate the device 26 a at the lesion level. Upon forming the desiredlesion pattern on a given level, the UGUI 504 again changes the thirdgraphical image to a fourth graphical image, different than the first,second, and third graphical images, comprising an edgewise cylinder witha number identification of its level, and further an indicator (e.g. acheck mark) that indicates all desired lesions have been formed at therespective level. A Marker 512 is successively updated to direct thephysician to the next Lesion Level. In this way, the UGUI 504 promptsthe formation of eight lesions circumferentially spaced 45-degrees apartin the Levels 1, 2, 3, and 4, and the formation of twelve lesionscircumferentially spaced 30-degrees apart at Lesion Levels 5 and 6.Thus, a total of 56 lesions can be formed in this procedure.

2. The LGUI

The LGUI 506 (FIG. 15A) generates a graphical user display that guidesthe physician in manipulating the device 26 b to form a prescribedlesion pattern in the anal canal, as shown in FIG. 9. The lesion patterncomprises a plurality of axially spaced lesion levels (in theillustrated embodiment, numbered 1 to 5), each lesion level comprising aplurality of circumferential spaced lesions (In the illustratedembodiment, there are sixteen lesions, arranged in sets of four).

The display of the LGUI 506 (see FIG. 15A) shows Lesion Levels 1, 2, 3,4, and 5, corresponding with the multiple lesion levels to be formed inthe anal canal. Lesion Levels 1 to 5 are displayed as segmented discs,numbered 1 to 5, which are tilted slightly on their axes, and arrangedone above the other. Each disc is divided into four quadrants.

The LGUI 506 also shows (see FIG. 15A) a dentate squiggle line 514. Inpreparation for the treatment, the physician visualizes in the analcanal dentate line or other desired anatomic landmark. Markers arearranged at 5 mm intervals along the barrel of the device 26 b. Uponvisualizing the dentate line, the physician notes the external marker onthe barrel that corresponds to this position. With reference to themarkers, the physician can then axially advance or retract the barrel in5 mm increments, which correspond to the spacing between the lesionlevels.

Next to the graphical form of the disc of Lesion Level 1 is a GuideMarker 512 (see FIG. 15A). The Guide Marker 512 indicates that formationof lesions in Lesion Level 1 is indicated. A numeric value (5 mm) isdisplayed in association with the edgewise cylinder of Lesion Level 1,which indicates that Lesion Level 1 is 5 mm from the anatomic landmark.

In FIG. 15A, all quadrants of the lesion level discs are unmarked. Thisgraphical form indicates at a glance that (i) formation of lesions atLesion Level 1 is now indicated (due to the position of the Marker 512)and (ii) no lesions have as yet been formed (by the lack of markings inthe quadrants).

The device 26 b includes an array of four needle electrodes arranged inan arc, which can be advanced and retracted (see FIG. 6). The array ofneedle electrodes is positioned at Level 1, in alignment with quadrant1, and advanced. The physician actuates the electrodes for a firstpre-set period. A Timer Icon 518 shows the application of radiofrequency energy for the pre-set period. At the end of this pre-setperiod, treatment indicia (e.g., four dots) appear in the first quadrantof the graphical segmented discs (see FIG. 15B), indicating theformation of the first four lesions, as well as their spatialorientation in the first quadrant.

The location of the Marker 512 also changes to align with Lesion Level2, with a numeric indicator of 5 mm. This informs the physician thatafter Lesion Level 1, the next lesion level will be Lesion Level 2,which is 5 mm above (superior to) Lesion Level 1.

Upon the satisfactory creation of the lesion pattern in the firstquadrant of Level 1, as just described, and as prompted by the Marker512 (now aligned with Lesion Level 2), the physician actuates the buttonto move the needle electrodes back to their retracted positions Stillgrasping the hand grip and visualizing through the viewing port, thephysician moves the barrel 5 mm axially upward to Level 2, remainingrotationally aligned in the first quadrant. The physician again deploysthe needle electrodes and performs another lesion generating sequence.The location of the Marker 512 also changes to align with Lesion Level3, with a numeric indicator of 5 mm. This informs the physician thatafter Lesion Level 2, the next lesion level will be Lesion Level 3,which is 5 mm above (superior to) Lesion Level 2. Treatment indicia(e.g., four dots) appear in the first quadrant of the graphicalsegmented disc of Lesion Level 2 (see FIG. 15C), indicating theformation of the four lesions, as well as their spatial orientation inthe first quadrant.

The physician repeats this sequence of steps until additional number oflesion patterns are formed within the axially spaced first quadrants inLevels 2, 3, 4, and (see FIGS. 15D, 15E, and 15F). The location of theMarker 512 also changes to align with successive Lesion Levels, to guidethe physician through the lesion levels. Treatment indicia (e.g., fourdots) appear in the first quadrant of the graphical segmented discs ofLesion Levels 2, 3, 4, and 5 (see FIG. 15F), indicating the formation ofthe four lesions, as well as their spatial orientation in the firstquadrant.

Upon formation of the four lesions in quadrant 1 of Lesion Level 5, theMarker 512 returns to Lesion Level 1 (see FIG. 15F), prompting thephysician to return to Lesion Level 1, and again rotate the barrel aselected arcuate distance at Lesion Level 1 into alignment with thesecond quadrant, i.e., by rotating the barrel by ninety degrees.

Guided by the LGUI 506, the physician again deploys the needleelectrodes and performs another lesion generating sequence at quadrant 2of Level 1. Guided by the LGUI 506 (as shown in FIG. 15G), and followingthe Marker 512, the physician then moves the barrel axially upward in 5mm increments, sequentially to quadrant 2 of Lesion Level 2, thenquadrant 2 of Lesion Level 3, then quadrant 2 of Lesion Level 4, andquadrant 2 of Lesion Level 5. At each Lesion Level, the physiciandeploys the needle electrodes and performs another lesion generatingsequence at quadrant 2 of the respective level. After lesion formationat each Lesion Level, treatment indicia (e.g., four dots) appear in thesecond quadrant of the graphical segmented discs of Lesion Levels 2, 3,4, and 5 (see FIG. 15G), indicating the formation of the four lesions,as well as their spatial orientation in the second quadrant.

Upon formation of the four lesions in quadrant 2 of Lesion Level 5, theMarker 512 returns to Lesion Level 1. The physician returns to LesionLevel 1, and again rotates the barrel a selected arcuate distance atLesion Level 1 into alignment with the third quadrant, i.e., by rotatingthe barrel by ninety degrees.

Guided by the LGUI 506 (see FIG. 15H), the physician again deploys theneedle electrodes 48 and performs another lesion generating sequence atquadrant 3 of Level 1. Treatment indicia (e.g., four dots) appear in thequadrant 3 of the graphical segmented disc of Lesion Levels 1,indicating the formation of the four lesions, as well as their spatialorientation in the third quadrant.

As shown in FIG. 15H, guided by the LGUI 506, and following the Marker512 as it advances with lesion formation at each level, the physicianthen moves the barrel axially upward in 5 mm increments, sequentially toquadrant 3 of Lesion Level 2, then quadrant 3 of Lesion Level 3, thenquadrant 3 of Lesion Level 4, and quadrant 3 of Lesion Level 5. At eachLesion Level, the physician deploys the needle electrodes and performsanother lesion generating sequence at quadrant 3 of the respectivelevel. Treatment indicia (e.g., four dots) appear in the third quadrantof the graphical segmented discs of Lesion Levels 2, 3, 4, and 5 (seeFIG. 15H), indicating the formation of the four lesions, as well astheir spatial orientation in the third quadrant.

The physician repeats the above described sequence one additional time,returning the barrel to Lesion Level 1 and rotating the barrel ninetydegrees into alignment with quadrant 4 of Lesion Level 1 (see FIG. 15I).The physician forms the lesion patterns quadrant 4 in the Levels 1, 2,3, 4, and 5. Treatment indicia (e.g., four dots) appear in the fourthquadrant of the graphical segmented discs of Lesion Levels 1, 2, 3, 4,and 5 (see FIG. 15B), indicating the formation of the four lesions, aswell as their spatial orientation in the second quadrant. In addition,with the formation of lesions in the fourth quadrant at each LesionLevel, the graphical disc representing the Lesion Level, each quadrantmarked by four dots (indicating completion of lesion creation) ischanged to additionally include an indicator, e.g., checkmark, toindicate that the respective Lesion Level has been treated (see FIG.15I).

As can be appreciated, there are twenty potential treatments with thedevice. That is, with the device deploying four needles, and ultimatelyfour treatments at each of the Levels 1-5, potentially 80 lesions can beformed. Note that each treatment is preferably timed for sixty seconds,although other cycles/intervals are also contemplated. Note also thateach needle electrode can be controlled independently.

As described, the LGUI 506 visually prompts a user in a step-wisefashion to perform a process of forming a pattern of lesions in the analcanal comprising a plurality of axially spaced lesion levels, eachlesion level comprising a plurality of circumferential spaced lesions.The LGUI 506 registers the formation of lesions as they are generated inreal time, both within and between each circumferentially spaced level.The LGUI 506 displays for the user a visual record of the progress ofthe process from start to finish and guides the user so that individuallesions desired within a given level are all formed, and that a givenlevel of lesions is not skipped.

Each Lesion Level 1 to 5 of the LGUI 506 is depicted by a first stylizedgraphical image comprising an edge-tilted disc with a numberidentification of its level. The discs are segmented corresponding tothe regions in which lesions to be formed. There also appears juxtaposedwith the next lesion level to be treated, a marker along with a numberindicating its distance from the present legion level. As the physicianmanipulates the device 26 b to form lesions on the indicated levels, thefirst graphical image further changes to a second graphical image,different than the first image, by adding indicia within the segmentedcircle to reflect the formation of lesions, to guide the physician asthe device is successively operated at the lesion level. Upon formingthe desired lesion pattern, the UGUI 506 again changes the secondgraphical image to a third graphical image, different than the first andsecond graphical images, comprising an indicator (e.g. a check mark)indicating that all desired lesions have been formed at the level. TheMarker 512 is updated to direct the physician to the next Lesion Level.In this way, the UGUI 506 prompts the formation of four lesions sets offour lesions each (totaling twelve lesions) circumferentially spacedapart in the Levels 1, 2, 3, 4, and 5.

During the procedure utilizing either of the radiofrequency treatmentdevices 26 a or 26 b, certain error messages are graphically indicatedon the GUI. Certain of these error messages relate to user errors whichcould be in the user's control, and therefore could potentially becorrectable by the user. For example, if there is an error in thetreatment device connection, the generator returns to the set up screenand the icon representing the treatment device displayed by the GUIbegins flashing. Another example is if the error relates to the returnpad, e.g., improper placement or contact of the pad, the generatorlikewise returns to the set up screen and the return pad icon displayedby the GUI begins flashing. Another example is if the needles are nottreated properly. With these errors indicated, the user can attempt tomake the proper adjustments, e.g., check the connection of the treatmentdevice, adjust the position of the return pad, etc. By easilyidentifying these correctible errors, the system will shut down fewertimes thereby enabling the creation of more lesions. Stated another way,the instrument continuously measures temperature which is transmittedback to the generator. The generator expects the temperature to be in acertain range. If the temperature does not appear right, e.g., isoutside an expected range, if the RF channel was immediately shut down,then it could result in premature/unnecessary termination of RF energywhich could undertreat tissue. Therefore, the present invention providessteps to ensure a shut down result is truly necessary, thusadvantageously limiting undertreatment of the tissue. Similarly, ifcalculated impedance from current measurement does not appear correct,i.e., is outside a desired range, e.g. 50-500 ohms for the instrument ofFIG. 6 and 50-100 ohms for the instrument of FIG. 2, the system of thepresent invention ensures that a channel shut down is warranted beforeshut down, again avoiding premature/unnecessary termination of RF energywhich can result in undertreatment of tissue.

The system, due to its faster processing speed which enables fasterprocessing of data and faster adjustment of parameters, enablesrechecking of detected errors to reduce the instances of prematurelyshutting down energy flow to an electrode. As discussed above, prematuretermination of energy flow can result in insufficient application ofthermal energy which in turn can result in undertreatment of tissue. Inother words, the system advantageously is designed to reduce the numberof events that would lead to energy cutoff to an electrode. Morespecifically, during the treatment cycles, oftentimes an error isdetected which can be readily addressed by the user, such as by a smalladjustment of the treatment device position if the error is caused forexample by patient movement which affects the impedance reading, or evenself-adjusts. If the system was designed to immediately shut down uponsuch error detection, then the electrode would be disabled and thelesion might not be created in that tissue region. Therefore, to reducethese occurrences, the system has been designed to recheck certainerrors.

More specifically, for certain detected errors, the system does notpermanently interrupt energy flow on the first error reading, butsuspends energy flow until a second check of the system is performed. Ifon the second check the error is no longer detected, energy flow isresumed. However, if on the second check, e.g.,re-measurement/calculation, an error still exists, the system runs yet athird check. If the error no longer exists, the energy flow resumes; ifthe error still exists, energy flow is cut off to that electrode at thattreatment position. Consequently, only after the system runs a triplecheck is a final determinations made to either transition back to energyflow or record the error and disable the electrode channel, i.e., shutdown RF energy flow to that electrode. Thus, the error can be checkedmultiple times to ensure it actually requires interruption of energyflow, thus avoiding premature disabling of an electrode to therebyenhance tissue treatment by not skipping tissue levels, or regions(quadrants) within each tissue level which could otherwise have beentreated. As a result, a more comprehensive and uniform tissue treatmentis achieved.

This triple error checking feature exemplifies the speed of theprocessor which enables quicker processing of temperature calculationsand quicker response to address rising temperatures so the tissue is nottreated above the tissue ablation threshold. As noted above, this tissueablation threshold can be exceeded if the energy is applied for too longa duration and/or too high a setting such that the tissue temperaturerises or applied for too long a duration once the tissue temperature hasreached the tissue ablation threshold before the flow of energy isterminated.

Also contributing to preventing overtreatment is to ensure the spacingbetween the electrodes in manufacture is precise so during applicationof energy, the amount of overlapping in a circumferential orientation isreduced. Such accurate and consistent spacing can also preventundertreatment such as if the two of the circumferential array ofelectrodes are undesirably angled or curved to much toward each other,that would mean they are angled further away from the electrode on theopposite side, possibly creating a gap in the treatment in acircumferential orientation. The axial distance of the electrodes canalso affect treatment. Therefore, maintaining the proper axial distanceof the electrodes, preferably with the tip terminating at the samedistal distance, and maintaining the proper radial distance of the tips,preferably evenly spaced along a circumference, will aid in maintainingthe treatment between the lower threshold and maximum threshold, i.e.,between undertreatment and overtreatment threshold.

The system, as noted above, also avoids ablating tissue due to carefuland more accurate calibration of the tissue temperature measurementmechanism. This is basically achieved by precisely calibrating the PCBso it can read the voltage generated by the thermocouples moreaccurately, reducing the likelihood of heating tissue beyond the tissueablation threshold. Thus, the PCB enables more accurate temperaturemeasurements which in turn allows the system to disable or make theappropriate adjustment, e.g., increasing cooling fluid application, whenthe temperature limits are reached.

While the above description contains many specifics, those specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision many other possible variations that arewithin the scope and spirit of the disclosure as defined by the claimsappended hereto.

1-19. (canceled)
 20. In a system for controlling operation of aradiofrequency treatment device to apply radiofrequency energy to tissueto heat tissue to create lesions at a treatment range defined betweenunder heating tissue to fail to achieve a therapeutic affect andoverheating tissue to cause tissue ablation, the system comprising acontroller including a connector to which a first treatment devicehaving a plurality of electrodes for applying radiofrequency energy totissue is coupled for use, and a generator for applying radiofrequencyenergy to the electrodes, the improvement comprising a multiple errorchecking system which if an error is detected which indicates disablingof an electrode of the plurality of electrodes of the treatment device,the system checks for a repeat of the error and determines if disablingis warranted or energy application is warranted to thereby reduce thelikelihood of undertreatment of tissue.
 21. The system of claim 20,wherein the multiple error checking system repeats the error check threetimes.
 22. A system for controlling operation of a radiofrequencytreatment device to apply radiofrequency energy to tissue to heat tissueto create lesions at a treatment range defined between under heatingtissue to fail to achieve a therapeutic effect and overheating tissue tocause ablation of tissue, the system comprising a controller including aconnector to which a first treatment device having a plurality ofelectrodes for applying radiofrequency energy to tissue is coupled foruse, and a generator for applying radiofrequency energy to theelectrodes, the controller controlling application of energy so that thetissue is thermally treated to create lesions but preventing thermaltreatment beyond a threshold which would ablate the tissue, the systemfurther including a cut off function to cut off energy flow to disablean electrode of the plurality of electrodes if one of multiple potentialerrors is detected, the system further containing a feature to preventpremature disabling of an electrode of the plurality of electrodes. 23.The system of claim 22, wherein the feature to prevent prematuredisabling of an electrode comprises a multiple error check in which ifan error is detected, a measurement is rechecked to determine if theerror is still present before cut off of energy flow.
 24. The system ofclaim 22, further comprising an automatic pump system to increase theflow of cooling fluid if measured temperature exceeds a predeterminedvalue.
 25. The system of claim 22, further comprising an operationsystem to execute on a display screen a first graphical interfaceguiding use of the first treatment device coupled to the controller, thecontroller visually prompting a user in a step-wise fashion to perform aprocess using the coupled treatment device of forming a pattern oflesions in a body region in a plurality of axially spaced lesion levels,each lesion level including a plurality of circumferential spacedlesions.
 26. The system of claim 22, wherein the first treatment deviceincludes a three dimensional basket and an expandable balloon within thebasket to expand the basket, the basket including a plurality of spinesand the plurality of electrodes are movable within the plurality ofspines.
 27. The system of claim 22, wherein the electrodes havepenetrating tips to penetrate tissue.
 28. The system of claim 24,wherein if the measured temperature reaches a second predeterminedvalue, the pump system is automatically moved to its maximum pump speedand cannot be overridden by a user.
 29. The system of claim 28, whereinif a third higher value is reached, the electrode is disabled, andfurther comprising an indicator to indicate if the electrode isdisabled.
 30. The system of claim 22, wherein the first treatment deviceincludes a handle and a shielded printed circuit board contained in thehandle, the printed circuit board enabling precise measurement of tissueand electrode parameters to regulate tissue temperature to preventthermal treatment of tissue beyond a tissue ablation threshold, and theshield reducing interference to minimize unwanted disabling ofelectrodes.
 31. The system of claim 30, wherein the printed circuit isasymmetrically mounted within the handle.
 32. The system of claim 30,wherein the printed circuit board includes a coded identification forthe first treatment device.
 33. The system of claim 22, wherein a codedidentification for the first treatment device is positioned in thehandle and a printed circuit board for temperature calculation ispositioned outside the handle.
 34. The system of claim 22, wherein if anerror is detected the system suspends energy flow but does notpermanently interrupt energy flow until the error is rechecked.
 35. Thesystem of claim 20, further comprising temperature sensors associatedwith the plurality of electrodes and an automatic pump system toincrease the flow of cooling fluid if measured temperature exceeds apredetermined value to maintain tissue temperature below a tissueablation threshold.
 36. The system of claim 20, wherein the firsttreatment device includes a plurality of temperature sensors, thetemperature sensors measuring temperature when the electrodes aredeployed at the lesion level but prior to application of RF energy toindicate to a user if electrode position needs to be adjusted.
 37. Thesystem of claim 20, wherein improper flow through a cable and throughthe electrodes is detectable.
 38. The system of claim 20, whereinimpedance is intermittently checked throughout a surgical procedureutilizing the first treatment device.
 39. The system of claim 20,wherein if an error is detected the system suspends energy flow but doesnot permanently interrupt energy flow until the error is rechecked.